Pharmaceutical Literacy and Quality of Life in Spanish Population.

• Conditions: Health Related Quality of Life; Literacy

• Registration Number: NCT06729697
• Lead Sponsor: University of Barcelona

Brief Summary

The goal of this study is to learn about the knowledge and abilities that patients have regarding their own medication and to see if that's related to their quality of life.

The main questions it aims to answer are:

* Are patients abilities and knowledge about their medications sufficient to ensure a safe and efective use?

* Are those knowledge and abilities related to the patient's quality of life? How?

Patients already taking at least one medication will answer questions about their abilities and knowledge towards medication and their quality of life related to their health state.

Detailed Description

A cross-sectional study is carried out, consisting of an interview between the patients and community pharmacists included in the study.

The participants selected are adults usually taking medication that answer questions related to their pharmaceutical literacy (RALPH interview). This type of literacy refers to three domains regarding functional, comunicative and critical abilities about their own medication.

After that, every participant answers a simple survey regarding their health-related quality of life including topics such as mobility, self-care, everyday activities, pain and mental health (EQ-5D-5L survey).

The recruitment and interviewing take place at the same time, and it requires less than 30 minutes per patient. No follow-up is needed afterward.

There are no risks associated with this procedure, and the participation of the patients will always be voluntary and anonymous.

Previously to the patients' enrollment in the study, proper information will be given to the potential participants and an informed consent will be signed.

Study Timeline

• Study Start: 2024-11-15
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1246

Inclusion Criteria

• Adults currently taking at least one medication prescribed by a physician and living in Spain.

Exclusion Criteria

• Having physical or cognitive limitations that make it impossible to answer the study questions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score	Through study completion, an average of 1 year.	A quantitative score will be obtained after an interview using the RALPH guide for community pharmacy. Only correct answered questions will add a point to the score. The values obtained stand between 0 and 10, and a higher score means a better outcome.
EQ-5D-5L index score	Through study completion, an average of 1 year.	A health state index score will be calculated from individual health profiles using the Spanish value set (Roudijk B, Ludwig K, Devlin N, Roudijk B, Ludwig K, Devlin N. EQ-5D-5L Value Set Summaries. Value Sets for EQ-5D-5L. 2022;55-212.) where the values stand between -0.166 and 1, and a higher score means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Time since the prescription of the medicine	Through study completion, an average of 1 year.	Time in months.
Sex	Through study completion, an average of 1 year.	Sex according to the categories: male or female.
Age	Through study completion, an average of 1 year.	Age in years.
Country of birth	Through study completion, an average of 1 year.	Name of the country of birth.
Level of education	Through study completion, an average of 1 year.	Education level according to the 4 categories: uneducated, primary education, secondary education and higher education.
Situation related to economic activity	Through study completion, an average of 1 year.	Economic activity according to the 7 categories: working, unemployed, retired, studying, unable to work, mainly engaged in housework and other situations.
Working time	Through study completion, an average of 1 year.	If working, type of working time according to the categories: full time and part time.
Total number of medicines prescribed per day	Through study completion, an average of 1 year.	Number of medicines prescribed per day according to the categories: less than 5 medicines and more than 5.

Trial Locations

Locations (1)

Clinical Pharmacy and Pharmaceutical Care Unit.; 🇪🇸 Barcelona, Spain